Assessment With CCTA and MRI in Asymptomatic Patients With Type 2 Diabetes for Detection of Unrecognized Myocardial Scar in Subclinical Coronary Atherosclerosis

NCT01254552 | Completed Phase 4 Results DMC

• 1 other identifier: ISO-44-011
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 1

Brief Summary

The study aimed to prospectively investigate the prevalence of myocardial scar on Dotarem-enhanced Cardiovascular Magnetic Resonance Imaging (MRI) in asymptomatic patients with type-2 Diabetes Mellitus and to assess its correlation with subclinical coronary artery disease on Cardiac Computed Tomography Angiography (CCTA).

Conditions

Type 2 Diabetes Mellitus; Coronary Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Prevalence of Occult Myocardial Scar on Delayed-enhanced MRI in Asymptomatic Patients With Type 2 Diabetes Mellitus

  From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations)

Secondary Outcomes (1)

• Number of Patients With and Without Occult Myocardial Scar on Cardiac MRI According to the Degree of Stenosis

  From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations)

Study Arms (1)

Dotarem and Xenetix 350

EXPERIMENTAL

Drug: iobitridol; Drug: gadoterate meglumine

Interventions

iobitridol DRUG

Xenetix 350 was administered at a dose up to 180 ml, according to the patient's body weight measured on the day of administration.

Also known as: Xenetix

Dotarem and Xenetix 350

gadoterate meglumine DRUG

Dotarem was administered at a dose of 0.1 mmol/kg body weight (0.2 ml/kg body weight)

Also known as: gadoteric acid, Dotarem

Dotarem and Xenetix 350

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with onset of type 2 diabetes occurred at age 30 years or older
• Patient between the ages of 50 and 75 years at enrolment time
• Patient with at least two identified cardiac risk factors who will undergo a CMR and a CCTA examinations to evaluate his/her coronary and cardiac status

You may not qualify if:

• Patient with angina pectoris or chest discomfort
• Patient with stress test or invasive coronary angiography within the prior 3 years
• Patient with history of myocardial infarction, overt non compensated heart failure, or coronary revascularization
• Patient with hemodynamic instability.
• Patient with a contraindication or intolerance to Beta-Blocker administration

Sponsors & Collaborators

• Guerbet: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Coronary Artery Disease

Interventions

iobitridol; gadoterate meglumine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Corinne Dubourdieu, Head of Clinical Projects and Medical Writing
• Organization: Guerbet

corinne.dubourdieu@guerbet.com

+33(0)1 45 91 50 00

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2010
• First Posted: December 6, 2010
• Study Start: August 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2016
• Last Updated: May 31, 2019
• Results First Posted: May 31, 2019

Record last verified: 2019-02

Locations

KR (1)